Custo Med Ergometer custo ec5000 Bedienungsanleitung

EXT 0001 - DK 1585

Version 001 – 2015-11-13

EL 20100043500

Operating Manual

Ergometer

custo ec5000

Manufacturer:

ergoline GmbH

Lindenstraße 5

72475 Bitz

Germany

Telefon: +49(0)7431 9894-0

Fax: +49(0)7431 9894-128

E-Mail: [email protected]

Internet: www.ergoline.com

Operating Manual

Ergometer

custo ec5000

This Operating Manual may not be copied in its entirety or in part, duplicated in any

form or by any means or translated into another language without the prior written

consent of custo med GmbH and ergoline GmbH.

The current version can be downloaded from this website: www.customed.de, in the

section SUPPORT, Manuals.

Distribution:

custo med GmbH

Leibnizstraße 7

85521 Ottobrunn

Germany

Phone: +49(0)89 710 98-00

Fax: +49(0)89 710 98-10

Email: [email protected]

Internet: www.customed.de

4Ergometer custo ec5000 | EXT 0001 – DK 1585 | Version 001 – 2015-11-13

General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

Setup and Mains Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Mounting the Control Terminal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Connecting the Power Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Connecting the Blood Pressure Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Connecting the SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Preparing the Patient for Blood Pressure Measurements . . . . . . . . . . . . . . .17

Checking the Cu Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Speed Readout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Handlebar Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Saddle Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Control Terminal Smart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Operating Mode with Control Terminal Smart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

PC Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Control Terminal Plus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Operating Modes with Control Terminal Plus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

PC Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Settings with Control Terminal Plus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Control Terminal Touch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35

Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Operating Modes with Control Terminal Touch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

PC Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Setup with Control Terminal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Cleaning, Maintenance, Disposal . . . . . . . . . . . . . . . . . . . . . . . . . .51

Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Electromagnetic Compatibility EN 60601-1-2 . . . . . . . . . . . . . . . . . . . 60

Ergometer custo ec5000 | EXT 0001 – DK 1585 | Version 001 – 2015-11-13

Contents

6Ergometer custo ec5000 | EXT 0001 – DK 1585 | Version 001 – 2015-11-13

Ergometer custo ec5000 | EXT 0001 – DK 1585 | Version 001 – 2015-11-13

GENERAL INFORMATION

• The product ec5000 bears the CE marking CE-0123

(Notied Body: TÜV), indicating its compliance with the

provisions of the Council Directive 93/42/EEC about

medical devices and fullls the essential requirements

of Annex I of this directive.

The CE marking covers only the accessories listed in

the Order Information chapter.

The device is an MDD class IIa product.

• The device fullls the requirements of standard

EN 60601-1 "Medical electrical equipment, Part 1:

General Requirements for Safety" as well as the

interference protection requirements of standard

EN 60601-1-2 "Electromagnetic Compatibility –

Medical Electrical Devices".

The radio-interference emitted by this product is with-

in the limits specied in EN 55011, class B.

• The symbol means: protection class II

• This manual is an integral part of the device. It should

be available to the device operator at all times. Close

observance of the information given in the manual

is a prerequisite for proper device performance and

correct operation and ensures patient and operator

safety. Please note that information pertinent to sever-

al chapters is given only once. Therefore carefully read

the manual once in its entirety.

• The symbols mean:

Consult accompanying documents.

They indicate points that are of particular importance

in the operation of the device.

• Observance of the safety information protects from

injuries and prevents inappropriate use of the device.

All device users and persons responsible for assembly,

maintenance, inspection and repair of the device must

read and understand the content of this manual, be-

fore using or working with it. Paragraphs with special

symbols are of particular importance.

• If unauthorized individuals open the control terminal,

damaging the calibration sticker, any warranty claim

shall become void.

• This manual reects the device specications and ap-

plicable safety standards valid at the time of printing.

All rights are reserved for devices, circuits, techniques,

software programs, and names appearing in this man-

ual.

• On request custo med will provide a Field Service

Manual.

• The custo med quality management system complies

with the standards ISO 9001: 2008 and EN ISO 13485:

2003-AC2007.

• The safety information given in this manual is classi-

ed as follows:

• To ensure patient safety, the specied measuring

accuracy, and interference-free operation, we recom-

mend using only original custo med accessories. The

user is responsible if accessories from other manufac-

turers are used.

• ergoline is responsible for the safety, reliability, and

performance of the device, only if

- modications and repair are carried out by

ergoline or by an organization expressly

authorized by ergoline.

- the device is used in accordance with the

instructions given in this operator's manual.

Danger

indicates an imminent hazard. If not avoided, the hazard will

result in death or serious injury.

Caution

indicates a potential hazard. If not avoided, the hazard may

result in minor injury and/or product/property damage.

Warning

indicates a hazard. If not avoided, the hazard may result in

minor injury and/or product/property damage.

ergoline GmbH

Lindenstraße 5

72475 Bitz

Deutschland

Telefon: +49 (0) 7431 98 94-0

Fax: +49(0)7431 98 94-128

E-Mail: [email protected]

Internet: www.ergoline.com

8Ergometer custo ec5000 | EXT 0001 – DK 1585 | Version 001 – 2015-11-13

Danger

• Explosion Hazard •

The device is not designed for use in areas where an explosion

hazard may occur.

Explosion hazards may result from the use of ammable anes-

thetics, skin cleansing agents or disinfectants.

Warning

• Patient Hazard, Equipment Damage •

Do not expose the ec5000 to direct sunlight to prevent system

components from reaching inadmissible high temperatures.

Do NOT use the ec5000 outdoors (medical device). Furthermore

the device has no additional protection against the ingress of

humidity. Humidity inside the device may cause equipment

malfunctions and increases the risk of an electric shock.

Additionally, the device should not be operated in the vicinity of

power systems, because they may impair equipment functions.

The ec5000 may only be used in combination with accessories

approved by custo med.

• Risk to Persons •

Before using the ergometer, the operator must ascertain that it is

in correct working order and operating condition. The cables and

connectors, in particular, must be checked for signs of damage.

Damaged parts must be replaced immediately.

• Equipment Malfunction •

Only the special shielded cables supplied by custo med may be

used to connect the device to other pieces of equipment.

• Equipment Malfunction •

Cellular telephones may not be used in the immediate vicinity

of the ergometer, because they might interfere with the proper

functioning of the ergometer.

Electromagnetic interference most probably exists when the

watt reading is unstable. If the displayed value changes fre-

quently even though the speed is above 30 RPM, this may be due

to electromagnetic interference.

Warning

• Shock Hazard •

When the ergometer is connected to other equipment or if a

medical system is created, it must be ensured that the added

leakage currents do not present a hazard. In case of questions,

please contact your custo med dealer or the custo med Service

Department.

For use, the ergometer must always be connected to electric

installations that fulll the local requirements.

• Patient Hazard •

The German Medical Device Operator Ordinance (MPBetreibV, § 5)

demands that users

• must be trained in the use of the ergometer

• must be familiar with the routines for handling and

assembly of the ergometer

• must be familiar with and observe the safety rules and

regulations for operation of this type of equipment

• must be informed about any other pertinent rules and

regulations (e.g. safety features)

• must be informed about the potential hazards arising from

the use of this type of equipment.

• make sure that no unauthorized changes are carried out.

SAFETY INFORMATION

Note

Only the removal of the power cord will result in an all pole

disconnection of the device from mains.

Caution

Additional equipment connected to medical electrical equip-

ment must comply with the respective IEC or ISO standards

(e.g. IEC 60950 for data processing equipment).

Furthermore all congurations shall comply with the require-

ments for medical electrical systems (see IEC 60601-1-1 or

clause 16 of the 3Ed. of IEC 60601-1, respectively).

Anybody connecting additional equipment to medical electrical

equipment congures a medical system and is therefore respon-

sible that the system complies with the requirements for medical

electrical systems. Attention is drawn to the fact that local laws

take priority over the above mentioned requirements.

If in doubt, consult your local dealer or custo med.

• IEC 60601-1+Al +A2:1995: 6.8.2.c, 19.2.b, 19.2.c,

• IEC 60601-1:2005: 7.9.2.5, 8.1, 16.2.d,

• MDD 93/42/EEC: Annex I clause 13.6.c

Ergometer custo ec5000 | EXT 0001 – DK 1585 | Version 001 – 2015-11-13

SAFETY INFORMATION FOR

NON-INVASIVE BLOOD PRESSURE

MEASUREMENT

Warning

• Patient Hazard •

Do not take blood pressure measurements with a cu on pa-

tients suering from sickle cell anemia or if skin lesions are likely

to occur.

The cu may cause hematomas in patients with severe blood

coagulation disease. In these instances, the user must take a

decision for or against automatic blood pressure measurements.

Caution

• Compromised Measuring Accuracy •

Arrhythmias occurring frequently during a measurement may

compromise the accuracy of the measurement.

Valid measurements may not be possible under certain circum-

stances.

Electromagnetic elds are also capable of impairing the measur-

ing accuracy.

Note

• If the cu pressure exceeds the maximum value of

300 mmHg during ination, the ination procedure will

be aborted and the cu deated. As a redundant safety

precaution, the cu is immediately deated when the cu

pressure exceeds 320 mmHg.

You can check the proper functioning of this safety precau-

tion by abruptly bending your arm while the cu is being

inated, causing a brief overpressure in the cu. The cu

must deate immediately.

• Measurements that did not yield a valid measurement will

not be repeated during the exercise test.

• If the ination phase takes longer than 40 seconds or if an

adequate pressure does not build up in the cu within a

reasonable period of time, the measurement will be aborted

and the cu deated.

• If a valid measurement cannot be completed within

120 seconds, the measurement will be aborted and the cu

deated.

• If the cu pressure remains constant for some time, the

measurement will also be aborted and the cu deated.

INTENDED USE

The ec5000 is a computer-controlled medical ergometer,

which operates at pedal speeds between 30 and 130 RPM

and loads between 6 and 999 W.

The speed-independent range is shown in the Appendix

(Specications).

The ec5000 ergometer may only be used in exercise testing

as well as for rehabilitation of cardiac and cardiovascular

patients according to the instructions given in this manual.

If the ergometer is used for other purposes, the manufac-

turer cannot be held liable for personal injuries or property

damage resulting from the unintended use of the equip-

ment.

Note - Applied Parts

• Applied parts are components that are directly in contact with

the human body (e.g., blood pressure measuring devices).

BIOCOMPATIBILITY

The parts of the product described in this manual,

including all accessories that come in contact with the

patient during the intended use, fulll the biocompatibil-

ity requirements of the applicable standards if applied as

intended.

If you have questions in this matter, please contact

custo med or one of their representatives.

APPLICABLE LAWS, REGULATIONS AND

DIRECTIVES

• 93/42/EEC (Medical Device Directive of the EU)

• 89/336/EEC (Electromagnetic Compatibility Directive of the EU)

• EN 1060-1 Non-invasive sphygmomanometers, Part 1:

General requirements

• EN 1060-3 Non-invasive sphygmomanometers, Part 3:

Supplementary requirements for electro-mechanical blood

pressure measuring systems

Note - Stability

• Ensure the stability of the ergometer. If the maximum per-

mitted patient weight is exceeded by 10%, the stability of

the ergometer can no longer be guaranteed. It may become

unstable as a result.

10 Ergometer custo ec5000 | EXT 0001 – DK 1585 | Version 001 – 2015-11-13

SYMBOLS

Symbol ’type B applied part’.

Type B applied parts have no direct contact with

patients and oer the lowest protection against

electric shock.

Symbol ’type BF applied part’.

Type BF applied parts are connected to the body

of the patient and provide a higher degree of pro-

tection against electric shock. The applied parts

are isolated.

Caution: Consult accompanying documents.

Protection class II equipment.

This symbol indicates that the waste of electrical

and electronic equipment must not be disposed of

as unsorted municipal waste and must be collected

separately.

Consult Operating Manual!

Order number.

Serial number.

Scheduled date of the next inspection

(e.g., March 2011).

Toggle switch ON (voltage).

Toggle switch OFF (voltage).

CE mark per the Medical Device

Directive 93/42/EEC of the European Union.

Notied body: TÜV SÜD Product Service GmbH,

Ridlerstr. 65, 80339 München, Germany.

Nationally Recognized Testing Laboratory

NRTL label for the USA and Canada.

REF

Manufacturer’s identication.

Date of manufacture.

The number found under this symbol is the year of

manufacture in the YYYY format.

PVC-free.

Latex-free.

Suitable for indicated arm circumference.

Small size.

Standard size.

Large size.

Transport and storage label:

top.

Transport and storage label:

keep dry.

Transport and storage label:

fragile.

Transport and storage label:

approved temperature range.

Transport and storage label:

approved humidity range, non-condensing.

Transport and storage label:

approved pressure range.

Transport and storage label:

do not stack.

Inhaltsverzeichnis

Andere Custo Med Heimtrainer Handbücher

Custo Med

Custo Med Ergometer ec3000 Bedienungsanleitung

Beliebte Heimtrainer Handbücher anderer Marken

Weslo

Weslo Vector 302 Kurzanleitung

TOORX

TOORX BRX85 Bedienungsanleitung

Matrix

Matrix KranKcycle Bedienungsanleitung

Matrix

Matrix IC3 Bedienungsanleitung

Sunny Health & Fitness

Sunny Health & Fitness SF-B121021 Bedienungsanleitung

Monark

Monark 827E Bedienungsanleitung

Stamina

Stamina 1310 Bedienungsanleitung

American Fitness

American Fitness SPR-BK1072A Bedienungsanleitung

Cateye

Cateye CS-1000 (CYCLO SIMULATOR) Bedienungsanleitung

BH FITNESS

BH FITNESS H9158H Bedienerhandbuch

Body Sculpture

Body Sculpture BC-7220G Bedienungsanleitung

Cateye

Cateye EC-2300 Bedienungsanleitung

FYTTER

FYTTER RACER RC MSR Bedienungsanleitung

Kikos

Kikos HM-9090M Bedienungsanleitung

Pro-Form

Pro-Form 345 Zlx Bike Benutzerhandbuch

Fuel Fitness

Fuel Fitness SU135-40 Bedienungsanleitung

NordicTrack

NordicTrack Gxr 4.2 Bike Bedienungsanleitung

Vision Fitness

Vision Fitness U70 Bedienungsanleitung